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史赛克T2 Alpha逆行股骨钉的机械故障

Mechanical Failure of the Stryker T2 Alpha Retrograde Femoral Nail.

作者信息

Lopas Luke A, Soni Chirag, Natoli Roman M, Jang Yohan, Milburn Mason, McKinley Todd O, Mullis Brian, Szatkowski Jan P

机构信息

Department of Orthopaedic Surgery, Indiana University School of Medicine, Indianapolis, IN; and.

John H. Stroger, Jr. Hospital, Chicago, IL.

出版信息

J Orthop Trauma. 2025 Apr 1;39(4):192-199. doi: 10.1097/BOT.0000000000002955.

DOI:10.1097/BOT.0000000000002955
PMID:39774644
Abstract

OBJECTIVES

To evaluate mechanical failure rates of retrograde femoral nails in the treatment of distal femur fractures.

DESIGN

Retrospective chart review.

SETTING

Urban Academic Level 1 Trauma Center.

PATIENT SELECTION CRITERIA

Included were adult patients who sustained a distal femur fracture (Arbeitsgemeinschaft fur Osteosynthesefragen Foundation/Orthopaedic Trauma Association 33) who were treated with a retrograde intramedullary nail from August 2021 through September 2022.

OUTCOME MEASURES AND COMPARISONS

The primary outcome was the rate of mechanical failure of the intramedullary nail defined as deformation and/or breakage of the intramedullary nail. The rate of mechanical failure was compared among retrograde femoral nails used at the same institution during the same time period.

RESULTS

One hundred and twenty distal femur fractures were identified (77 native distal femur, 43 periprosthetic) that were treated with a retrograde intramedullary nail. Average patient age was 67 years (SD 15.1, range 18-96 years). Eighty-three (69.2%) patients were women. Four mechanical nail failures (deformation and/or breakage of the intramedullary nail) were observed within 6 months of surgery, 2 in patients with native distal femur fractures and 2 in patients with periprosthetic distal femur fractures. All failures occurred among 49 fractures treated with a newly released retrograde femoral nail, the T2 Alpha Retrograde Femoral Nail (Stryker, Mahwah, NJ). This represents an 8.2% mechanical failure rate of distal femur fractures treated with this new nail compared with no failures observed with any other nail ( P = 0.03).

CONCLUSIONS

Mechanical nail failures, within 6 months of surgery for distal femur fracture, of a new retrograde femoral nail were observed to be higher than seen with other nails. Further evaluation is needed to determine whether this experience represents factors related to patient, injury, or surgical characteristics, an anomaly, or a safety signal.

LEVEL OF EVIDENCE

Prognostic Level III. See instructions for authors for a complete description of levels of evidence.

摘要

目的

评估逆行股骨钉治疗股骨远端骨折的机械故障率。

设计

回顾性病历审查。

地点

城市一级学术创伤中心。

患者选择标准

纳入2021年8月至2022年9月期间接受逆行髓内钉治疗的股骨远端骨折( Arbeitsgemeinschaft fur Osteosynthesefragen Foundation/骨科创伤协会33型)成年患者。

结局指标及比较

主要结局是髓内钉的机械故障率,定义为髓内钉变形和/或断裂。比较同一机构在同一时期使用的不同逆行股骨钉的机械故障率。

结果

共识别出120例接受逆行髓内钉治疗的股骨远端骨折(77例原发性股骨远端骨折,43例假体周围骨折)。患者平均年龄为67岁(标准差15.1,范围18 - 96岁)。83例(69.2%)为女性。术后6个月内观察到4例髓内钉机械故障(髓内钉变形和/或断裂),2例原发性股骨远端骨折患者,2例假体周围股骨远端骨折患者。所有故障均发生在49例使用新发布的逆行股骨钉T2 Alpha逆行股骨钉(史赛克公司,新泽西州马哈瓦)治疗的骨折中。与其他钉子未观察到故障相比,使用这种新钉子治疗的股骨远端骨折的机械故障率为8.2%(P = 0.03)。

结论

观察到一种新型逆行股骨钉在股骨远端骨折术后6个月内的机械故障率高于其他钉子。需要进一步评估以确定这种情况是与患者、损伤或手术特征相关的因素、异常情况还是安全信号。

证据级别

预后III级。有关证据级别的完整描述,请参阅作者指南。

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